The Supria system is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes.

The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA). Multi-planar reconstruction (MPR) and volume rendering.

Volume datasets acquired by the Supria can be transferred to external devices via a DICOM standard interface. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.

Device Description

The SUPRIA is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 16-detector technology. The system allows optimum clinical applications ranging from routine exams in response to the diversified circumstances in imaging whole body regions.

The SUPRIA system uses 16-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 16 slices of data simultaneously. The X-rav sub-system features a high frequency generator. X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles.

The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system.

The SUPRIA system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria with numerical performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device (SCENARIA Phase 2 Whole-body X-ray CT System K123509) through comparison of technological characteristics and general performance.

Here's an attempt to extract and synthesize the requested information based on what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria. Instead, it relies on demonstrating that the SUPRIA w/guideShot Option has "equivalent basic performance" or "comparable performance" to the predicate device, SCENARIA Phase 2. The 'Performance' section within the "Device Technological Characteristics" table offers some numerical comparisons for specific aspects:

Item	Acceptance Criteria (Predicate SCENARIA Phase 2)	Reported Device Performance (SUPRIA w/guideShot Option)
High-contrast spatial resolution	0.35 [mm]	0.35 [mm]
Low-contrast resolution	2.5 [mm] @ 0.25%	2.5 [mm] @ 0.25%
10% MTF	15.1 [lp/cm]	15.1 [lp/cm]
50% MTF	12.1 [lp/cm]	12.1 [lp/cm]
Reconstruction Time	0.2 seconds per image or less	0.1 seconds per image or less
Max. Scan Time	100 [s]	100 [s]
Storage Images	200,000	200,000

Note: The "Acceptance Criteria" column is inferred from the predicate device's specifications, as the goal is to show equivalence. The "Reported Device Performance" column directly reflects the SUPRIA's specifications as listed. The document states that the SUPRIA's performance characteristics are "comparable" or "generally equivalent" to the predicate, and for some specific metrics like reconstruction time, SUPRIA even shows improved performance.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document mentions that "clinical images were collected and analyzed" and that "clinical image examples" were provided. However, it does not specify a numerical sample size for this clinical image collection.
Data Provenance: Not explicitly stated. The document simply refers to "clinical images." It does not mention the country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document states, "We provide clinical image examples which we judged to be sufficient to judge a clinical usability." This implies an internal assessment.

Number of Experts: Not specified.
Qualifications of Experts: Not specified. It only mentions "we judged," which could refer to the manufacturer's internal team.

4. Adjudication Method for the Test Set

Not specified. The document only mentions that "clinical images were collected and analyzed" and "judged to be sufficient to judge a clinical usability." There is no indication of a formal adjudication process (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Was an MRMC study done? No, the document does not indicate that an MRMC comparative effectiveness study was conducted. The evaluation focuses on the device's technical specifications and a comparison to a predicate device, rather than human reader performance with and without AI assistance.
Effect size of human readers with AI vs. without AI assistance: Not applicable, as no MRMC study involving AI assistance for human readers was reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device itself is a Computed Tomography (CT) system (hardware and software for image acquisition and basic post-processing), not an AI algorithm for diagnosis. The "guideShot Option" adds remote in-room display and controls for interventional imaging. Therefore, the concept of a "standalone algorithm" performance as typically evaluated for AI-driven diagnostic tools is not directly applicable here. The focus is on the performance of the CT system in producing images, which are then used by a physician.

7. The Type of Ground Truth Used

The document mentions "clinical image examples" which were "judged to be sufficient to judge a clinical usability." This suggests the ground truth was based on:

Expert Clinical Judgment/Usability: The images were evaluated to confirm they met clinical usability standards, likely by qualified personnel. It does not mention pathology, outcomes data, or a formal consensus process as a "ground truth" for diagnostic accuracy of an AI model within the system.

8. The Sample Size for the Training Set

Not applicable. The SUPRIA w/guideShot Option is a computed tomography x-ray system, not primarily an AI algorithm that undergoes "training" in the conventional sense of machine learning for image interpretation. The device's software includes image reconstruction and post-processing capabilities, which are based on established scientific principles and algorithms, not a training set of images with ground truth for learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set or AI model training in the context of this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, stacked on top of each other, with flowing lines above them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 17, 2016

Hitachi Medical Systems America, Inc. % Mr. Doug Thistlethwaite Manager of Regulatory Affairs 1959 Summit Commerce Park TWINSBURG OH 44087

Re: K161748

Trade/Device Name: SUPRIA w/ guideShot Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 16, 2016 Received: June 24, 2016

Dear Mr. Thistlethwaite:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161748

Device Name SUPRIA w/ guideShot Option

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Section 5

510(k) Summary

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Submitter Information
Submitter:	Hitachi Medical Systems America, Inc.1959 Summit Commerce ParkTwinsburg, Ohio 44087-2371
Contact:	Douglas J. Thistlethwaite
Telephone number:	330-425-1313
Telephone number:	330-963-0749
E-mail:	thistlethwaited@hitachimed.com
Date:	June 16, 2016

Submitter Information

Device Name

Regulation Number:	21 CFR 892.1750
Regulation Name:	Computed tomography x-ray system
Product Code	JAK, System, X-Ray, Tomography, Computed
Class	II
Panel	Radiology
Trade/Proprietary Name:	SUPRIA w/guideShot Option
Predicate Device(s):	SCENARIA Phase 2 Whole-body X-ray CT System (K123509)

Device Intended Use

The SUPRIA system is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes.

The volume datasets acquired by the SUPRIA can be post processed by the system to provide additional information. Post processing capabilities included in the SUPRIA software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.

Volume datasets acquired by the SUPRIA can be transferred to external devices via a DICOM standard interface.

The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.

Device Description

Function

Scientific Concepts

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Physical and Performance Characteristics

The SUPRIA system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories. The system performance is similar to the predicate device.

Performance Comparison

A clinical evaluation comparison was conducted with the SUPRIA quideShot system and the SCENARIA Phase 2 quideShot System (K123509) and found to be substantially equivalent.

A rationale analysis was then conducted and the results are contained in Table 1.

Table 1 Performance Comparison Analysis
-----------------------------------------	--

Testing Type	Rationale Analysis
Performance Testing - Clinical	Using a phantom, clinical images have been provided which confirm the SUPRIA w/guideShot Option has equivalent basicperformance as the predicate device, SCENARIA Phase2.
Performance Testing - Bench	Additional bench performance testing was determined to be unnecessary do to the fact no technological changes haveoccurred since the original submission except the addition of the guideShot feature to the SUPRIA.

The analysis confirms the performance characteristics of the SUPRIA are comparable to the predicate device and support our conclusion that the SUPRIA system is substantially equivalent.

Device Technological Characteristics

The following comparison tables are exactly the same as those submitted with the original SUPRIA submission (K150565) except the guideShot feature is now available on the SUPRIA.

ITEM	SUPRIA w/guideShot Option	SCENARIA Phase 2 Whole-bodyX-ray CT System (K123509)	Difference Analysis
Gantry
Geometry	Rotate-rotate with offset detectorsystem, slip ring	Rotate-rotate with offset detectorsystem, slip ring	No
Scan Time	0.75, 1.0, 1.5, 2.0 [s]	0.35, 0.4, 0.5, 0.75, 1.0, 2.0 [s]	Table 3: 01
X-ray Fan Beam Angle	51 [deg]	51 [deg]	No
Gantry Tilt	-30 to +30 [deg]	-30 to +30 [deg]	No
Gantry Aperture	750 [mm]	750 [mm]	No
Gantry Dimensions	1990 x 920 x 1842.5 [mm]	2350 x 880 x 2030 [mm]	Table 3: 02
Gantry Weight	1600 [kg]	2235 [kg]	Table 3: 02
Scan Localizer	Laser	Laser	No
Detector
Type	Solid state	Solid state	No
Number of Channels	880 [ch] (8ch reference)	888 [ch] (8ch reference)	Table 3: 03
Number of Rows	16	64	Table 3: 03
Number of Slices	16 [slice/scan] (Axial)	64, 128 [slice/scan] (Axial)	Table 3: 03
X-ray Tube
Anode Heat Storage	5 [MHU]	7.5 [MHU]	Table 3: 04
Dissipation Rate	470 [kHU/min]	1,386 [kHU/min]	Table 3: 04
Tube cooling	Oil/air	Cooling Fluid/air	Table 3: 04
Tube focal spot	Dual 0.7 x 0.8, 1.2 x 1.4 [mm]	Dual 0.7 x 0.8, 1.2 x 1.4 [mm]	No
ITEM	SUPRIA w/guideShot Option	SCENARIA Phase 2 Whole-bodyX-ray CT System (K123509)	Difference Analysis
X-ray Generator
kW Output	System Maximum 48[kW] /Generator Maximum 51 [kW]	72 [kW]	Table 3: 05
Max. Power Input	75 [kVA]	100 [kVA]	Table 3: 05
kVp Range	80, 100, 120, 140 [kVp]	80, 100, 120, 140 [kVp]	No
mA Range	10 to 400 [mA] @120kV, 48kW	10 to 600 [mA] @120kV, 72kW	Table 3: 05
Patient Table
Range of Movement,Vertical	450 to 1000 [mm] (CT-WT-21)	465 to 1050 [mm] (CT-WT-19)450 to 1050 [mm] (CT-WT-18L)	Table 3: 06
Range of Movement,Longitudinal	1910 [mm] (CT-WT-21)	2110 [mm]	Table 3: 06
Range of Movement,Lateral	N/A	-80 to +80 [mm] (CT-WT-19)	Table 3: 06
Scannable Range	155 cm	175 cm	Table 3: 06
Maximum Load Capacity	227 [kg]	230 [kg]	Table 3: 06
Display
Monitor Type	24" LCD	24" LCD	No
Matrices, Pixels	1920 x 1200	1920 x 1200	No
Image Enlargements	Up to 9.99x	Up to 9.99x	No
Max. Slices Displayed at Once	25	25	No
Image Storage
Hard Disk	110 [GB] (images),200 [GB] (raw data)	250 [GB] (images),750 [GB] (raw data)	Table 3: 07
Storage Images	200,000	200,000	No
Archival Storage (Media)	DVD-R/RW, CD-R/RW	DVD-RAM, DVD-R/RW,CD-R/RW	Table 3: 07
Scanning, Reconstruction
Localization Scan	Real time	Real time	No
Localization Scan Length	150, 250, 350, 500, 750,1000, 1250, 1500, 1750 [mm]	150, 250, 350, 500, 750,1000, 1250, 1500, 1750 [mm]	No
Max. Scan Time	100 [s]	100 [s]	No
Helical Beam Pitch	0.56, 0.81, 1.06, 1.31, 1.56	0.58, 0.83, 1.08, 1.33, 1.58@40mm Collimation	Table 3: 08
Collimation	1.25, 5, 10 [mm]	1.25, 5, 10, 15, 20, 40 [mm]	Table 3: 08
Reconstruction Matrix	512 x 512 [pix]	512 x 512 [pix]	No
Reconstruction FOVs	20 to 500 [mm]	20 to 500 [mm]	No
Slice Thickness	0.625, 1.0, 1.25, 2.5, 3.75,5.0, 7.5, 10.0 [mm]	0.625, 1.0, 1.25, 2.5, 3.75,5.0, 7.5, 10.0 [mm]	No
Range of CT numbers	-2000 to +4000 (13bit)-32768 to +32767 (16bit)	-2000 to +4000 (13bit)-32768 to +32767 (16bit)	No
Reconstruction Time	0.1 seconds per image or less	0.2 seconds per image or less	Table 3: 09
Performance
High-contrast spatial resolution	0.35 [mm]	0.35 [mm]	No
Low-contrast resolution mm at % at ≤4rads	2.5 [mm] @ 0.25%	2.5 [mm] @ 0.25%	No
10% MTF	15.1 [lp/cm]	15.1 [lp/cm]	No
50% MTF	12.1 [lp/cm]	12.1 [lp/cm]	No
Dose Controls
Bow Tie Filter	Yes. Normal	Yes. Small / Normal	Table 3: 10
Automatic Exposure Control	Yes. IntelliEC	Yes. IntelliEC	No
Longitudinal Modulation	Yes	Yes	No
Angular Modulation	Yes	Yes	No
Iterative Reconstruction	Yes. Intelli IP Advanced Mode	Yes. Intelli IP Advanced Mode	No
Maximum possible pitch with full imagequality	1.56	1.58	Table 3: 11
ITEM	SUPRIA w/guideShot Option	SCENARIA Phase 2 Whole-bodyX-ray CT System (K123509)	Difference Analysis
Dose Displays
CTDIv	Yes	Yes	No
DLP	Yes	Yes	No
Features
Axial Scan	Yes	Yes	No
Helical Scan	Yes	Yes	No
Dynamic Scan	Yes	Yes	No
Predict Scan	Yes	Yes	No
ECG Retrospective Scan(Helical)	No	Yes	Table 3: 12
ECG Prospective Scan(Axial)	No	Yes	Table 3: 12
guideShot Scan	Yes	Yes	No
Automatic Exposure Control	Yes.	Yes. IntelliEC	No
Automatic Exposure Control using IterativeReconstruction	No.	No.	No
ECG Dose Modulation	No	No.	No
Adaptive Filter	No	Yes. Intelli IP Normal	Table 3: 13
Iterative Reconstruction	Yes. Intelli IP Advanced	Yes. Intelli IP Advanced	No
Injector Synchronization	Yes	Yes	No
Dose Check	Yes	Yes	No
Access Control	Yes	No	Table 3: 14
Automatic Cardiac Phase Search	No	Yes. CardioHarmony	Table 3: 12
Preview Scan	No	No	No
Double Slice at Axial Scan	No	Yes. Fine Recon	Table 3: 15
Priority Recon.	No	No	No
Dose Report	Yes. Simple Dose Report	Yes. Simple Dose Report	No
DICOM	Yes	Yes	No
ID Reader	Yes	No	Table 3: 16
Exam Split	Yes	No	Table 3: 17
Multi-Planar Reconstruction (MPR)	Yes	Yes	No
Volume Rendering	Yes	Yes	No
CT Angiography (CTA)	Yes	Yes	No
Segmentation	Yes	Yes	No
Retouch	Yes	Yes	No
Quality Exam	Yes	No	Table 3: 18

Table 2 Technological Characteristic Differences

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The differences from the predicate device to SUPRIA are explained in Table 3.

Table 3 Analysis of Differences

Gantry
01	Because the specifications of the device are different, the minimum scan time of this device is not as short as the Predicate. Thischange does not affect overall technological characteristics compared to the Predicate.
02	Because the specifications of the device are different, the size and the weight of the Gantry of this device are different from thePredicate. However, as the device weighs less and has a smaller footprint than the Predicate, we judge that these changes do notimpact the intended use.
Detector
03	Because the number of provided slices for one rotational scan is different per equipment specifications, there are fewer number ofdetectors and number of the channels than the Predicate.
X-ray Tube
04	The X-ray tube of this device is different from Predicate only in heat capacity. The X-ray tube focal spot and general performancecharacteristics are the same as the Predicate.

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X-ray Generator
05	The X-ray generator was selected to match the performance specifications of this device and conforms to IEC60601-2-44-2009 requirements for CT systems. The kVp and mA output of the device is comparable to the Predicate.
Patient Table
06	The scannable range specification was defined assuming the number of the provided slices by one rotational scan is approximately 25% of Predicate, and the table travel and weight capacity specifications are generally equivalent to the Predicate.
Image Storage
07	The data output volume of this device is approximately 25% of Predicate and the volume of the hard disk drive (HDD) was defined to give an equivalent exam capacity as the Predicate.In addition, we select commonly available external output media that is both easy to obtain and meets the device specification requirements.
Scanning, Reconstruction
08	The helical scan pitch specification is based on the table movement distance and collimation width, but is nearly identical to the Predicate.
09	The data processing load of this device is approximately 25% of Predicate and the computing capacity was defined to achieve an equivalent performance specification compared to the Predicate.
Dose Controls
10	While this device is not equipped with a small Bow-Tie Filter, the normal Bow-Tie Filter provides generally equivalent performance to the Predicate and does not substantially impact the effectivity and safety of this device.
11	As noted above, the pitch specification is only marginally different and therefore does not substantially alter the device performance as compared to the Predicate.
Features
12	This device is a general purpose CT system that is not equipped with an ECG function. The lack of ECG does not substantially affect the intended use of the device and does not impact the effectivity and safety of this device as compared to the Predicate.
13	This device is not equipped with an Adaptive Filter function, but has an Iterative Reconstruction feature which provides an equivalent image processing function.
14	This function is intended to confirm device performance according to IEC 62351-8 and NEMA XR-26.
15	This device is not equipped with a Fine Recon function which does not impact the effectivity and safety of this device.
16	This function supports the input of patient information by a bar code reader.
17	This function is for dividing one examination into multiple examinations (with unique Accession numbers) as an operator convenience.
18	This function is intended to confirm device performance according to IEC 61223-3-5/IEC 61223-2-6.

Therefore, based on a thorough analysis and comparison of the SUPRIA and the predicate device, the technological characteristics do not impact safety and effectiveness.

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Substantial Equivalence

A summary decision was based on analysis of Table 4.

Table 4 Rationale Analysis: SUPRIA vs. Predicate

ITEM	Overall Rationale Analysis
GantryDetector	Different specifications do not constitute a new intended use. There are no significant changes in technologicalcharacteristics. The gantry and detector design was based on the same technology as the Predicate. These sub-systemshave the same level of general effectiveness as the Predicate based on the performance test results shown in Section 10.
X-ray Tube	For safety, these items are controlled and tested according to same regulations and/or standards as the Predicate.
X-rayGenerator	This item conforms to IEC60601-2-44-2009 requirements for CT systems and has the same level of general effectivenessas the Predicate based on the performance test results shown in Section 10. For safety, this item is controlled and testedaccording to same regulations and/or standards as the Predicate.
Patient Table	Different specifications do not constitute a new intended use. There are no significant changes in technologicalcharacteristics. The table travel and weight capacity characteristics are generally equivalent to the Predicate. For safety,this item is controlled and tested according to same regulations and/or standards as the Predicate.
Display	There are no functional differences in this item.
Image Storage	Different specifications do not constitute a new intended use. There are no significant changes in technological
Scanning,Reconstruction	characteristics. The design criteria for these elements were set to allow comparable performance to the Predicate. Theperformance of these sub-systems does not substantially affect the effectivity and safety as compared to the Predicate andwere verified by design V&V1.
Performance	There are no substantial differences in this category based on the performance test results from the original submission.
Dose Controls	Different specifications do not constitute a new intended use. There are no significant changes in technologicalcharacteristics. For safety, these items are controlled and tested according to same regulations and/or standards as thePredicate.
Dose Displays	There are no functional differences in this item.
Features	Different specifications do not constitute a new intended use. There are no significant changes in technologicalcharacteristics and the feature set of the device is generally equivalent to the Predicate.

Therefore, based on a thorough analysis and comparison of the functions, scientific concepts, physical and performance characteristics, performance comparison and technological characteristics, the proposed SUPRIA w/guideShot Option is considered substantially equivalent to the currently marketed predicate device (SCENARIA Phase 2 Whole-body X-ray CT System (K123509)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.

1 Certified by the Declaration of Conformity with Design Controls in Section 1.

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Summary of Non-Clinical Testing

The SUPRIA system is in conformance with the applicable parts of the following standards:

AAMI ANSI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and ● A2:2010/(R)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2 Edition 3: 2007 . Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
. IEC 60601-1-3 Edition 2.0 2008-01

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

IEC 60601-2-44 Edition 3.0 2009-02 . Medical electrical equipment Part 2-44: particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography.
NEMA XR 25

Computed tomography dose check. (Radiology)

. NEMA XR 26
Access Controls for Computer Tomography: Identification, Interlocks, and Logs
IEC 62304 First edition 2006-05, Medical device software Software life cycle processes 0
In addition, the device complies with all applicable requirements for Dose Profile, Noise, Mean CT number and Uniformity, Spatial Resolution, Tomographic Section Thickness and Sensitivity Profile, Tomographic Plane Location, and CT dose index.

Summary of Clinical Testing

Clinical images were collected and analyzed to ensure that the SUPRIA w/guideShot Option will meet user needs.

As a result of the analysis:

Testing Type	Rationale Analysis
Performance Testing - Clinical	We provide clinical image examples which we judged to be sufficient to judge a clinical usability.

Conclusions

Hitachi believes that, based on the information included in the submission and the original submission, SUPRIA w/guideShot Option is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the SCENARIA Phase 2 Whole-body X-ray CT System (K123509).

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.